Duray Gabor Z, Ritter Philippe, El-Chami Mikhael, Narasimhan Calambur, Omar Razali, Tolosana Jose M, Zhang Shu, Soejima Kyoko, Steinwender Clemens, Rapallini Leonardo, Cicic Aida, Fagan Dedra H, Liu Shufeng, Reynolds Dwight
Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
Department of Cardiac Pacing and Electrophysiology, CHU/Université de Bordeaux, Pessac, France.
Heart Rhythm. 2017 May;14(5):702-709. doi: 10.1016/j.hrthm.2017.01.035. Epub 2017 Feb 10.
Early performance of the Micra transcatheter pacemaker from the global clinical trial reported a 99.2% implant success rate, low and stable pacing capture thresholds, and a low (4.0%) rate of major complications up to 6 months.
The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months.
The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates.
The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years.
Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
全球临床试验报告显示，Micra经导管起搏器早期表现出99.2%的植入成功率、低且稳定的起搏夺获阈值，以及长达6个月时4.0%的低严重并发症发生率。
本报告旨在描述Micra在12个月时预先设定的长期安全性目标以及至24个月时的电学性能。
Micra经导管起搏研究是一项前瞻性单臂研究，旨在评估Micra VVIR无导线/心内起搏器的安全性和有效性。入组患者符合I类或II类指南中关于初发心室起搏的推荐。长期安全性目标是在12个月时无系统或手术相关的严重并发症。使用一个由2667例植入经静脉起搏器患者组成的预先定义的历史对照组来比较严重并发症发生率。
实现了长期安全性目标，12个月时严重并发症发生率为96.0%（95%置信区间94.2%-97.2%；与性能目标相比P <.0001）。Micra植入患者（N = 726）在植入后12个月内发生严重并发症的风险比经静脉系统植入患者低48%（风险比0.52；95%置信区间0.35-0.77；P =.001）。在年龄、性别和合并症亚组中，与经静脉系统相比，Micra降低了严重并发症的风险。至24个月时电学性能良好，预计电池寿命为12.1年。
Micra经导管起搏器的长期性能与先前报告的数据一致。在12个月的随访中，很少有患者发生严重并发症，与经静脉起搏器历史对照组相比，所有患者亚组均从中受益。
